Facilities & Capacity Archives - Page 22 of 73 - BioProcess InternationalBioProcess International

BioNTech aiming to bring mRNA manufacturing to Asia

BioNTech will boost its mRNA capacity by building a facility in Singapore. Meanwhile a joint venture with Fosun Pharma looks to bring its COVID-19 vaccine to China. BioNTech’s BNT162b2 became the first messenger RNA (mRNA) COVID-19 vaccine to receive emergency use approval in December 2020. Since then, 450 million doses of the vaccine have been shipped to 91 countries from the firm’s manufacturing facilities in Germany and its partner Pfizer US and European production network. Now the firm is looking…

Allogene and Regenxbio point to inhouse CGT advantage

by Dan Stanton

With facilities set to come online in California and Maryland, Allogene and Regenxbio respectively are the latest advanced therapy firms to laud the advantages of inhouse production. Allogene launched in 2018 with backing from Pfizer and has progressively been developing its AlloCAR T allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. Its lead candidate is ALLO-501A looking to move into Phase II studies for Non-Hodgkin Lymphoma later this year. The company hopes to support the trial and beyond through…

Catalent bolsters pDNA biz with Promethera buy

by Millie Nelson

Contract development manufacturing organization (CDMO) Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support (HCTS). No financial details have been disclosed. Catalent gains a 32,400 square-foot plant located on in Gosselies, Belgium. The facility will be used for commercial-scale plasmid DNA (pDNA) production and is next to the Delphi Genetics building, which the firm acquired in February expanding its pDNA offering. “With this investment, Catalent will now be able to offer cell therapy and gene therapy customers…

Lonza to up mammalian bioreactor capacity by 136,000L

by Millie Nelson

Lonza has invested $935 million to expand its mammalian manufacturing facilities in Visp, Switzerland and Portsmouth, US. Swiss contract development manufacturing organization (CDMO) Lonza will construct a large-scale stainless-steel plant in Visp and a small-scale, single-use technology facility in Portsmouth to respond to customer demand for mammalian drug substance production. “At Lonza, we are focused on supporting our customers to achieve efficient, high-throughput production processes and flexible manufacturing solutions,” said Jean-Christophe Hyvert, president, Biologics and Cell & Gene, Lonza. He added: “Our customers’ needs range from the manufacture of small- to mid-volume…

Fill & finish investments plus pandemic drive Catalent’s biologics biz

by Millie Nelson and Dan Stanton

Biologics now represent over half of Catalent’s revenues with the firm citing drug product manufacture as a major driver. For a number of years, contract development manufacturing organization (CDMO) Catalent has been tipping the balance of its business away from its small molecule and delivery technology heritage, and towards its biologics business. The biologics business pulled in around 32% of Catalent’s business mix in 2019, but in under two years the division pulled in over half of the CDMO’s net revenues…

Lack of AAV capacity drives $120m investment for Forge Biologics

by Millie Nelson

Forge Biologics has closed $120 million in Series B financing to expand its AAV manufacturing capabilities and develop gene therapies. The gene therapy contract development manufacturing organization (CDMO) Forge Biologics has raised $120 million with finances led by RA Capital Management, Octagon Capital, Surveyor Capital (a Citadel company), and Marshall Wace. According to Forge, the funding will fast-track the expansion of its adeno-associated virus (AAV) manufacturing CDMO capabilities and capacity and work with its subsidiaries that are developing AAV gene…

GMP deficiencies disrupt production of ERC’s cell-based vaccine

by Dan Stanton

European regulators have suspended the distribution of autologous and allogeneic cell-based vaccine candidate Gliovac following an inspection at ERC’s site in The Netherlands. The inspection took place on February 25 at the Schaijk facility, located about 75 miles southeast from Amsterdam, and resulted in a statement of non-compliance with good manufacturing practice (GMP) being issued. “ERC The Netherlands B.V. showed a lack of ability to adhere to the principles of Good Manufacturing Practice for ATMPs [advanced therapy medicinal products],” the…

Emergent recognized cross contamination risk at Bayview plant hit with 483

by Dan Stanton

Emergent BioSolutions has defended the manufacture of two different viral products from its Bayview facility as part of the “Herculean task” of tackling the coronavirus pandemic. The Bayview, Maryland drug substance facility has been on the forefront of the fight against COVID-19, with Emergent BioSolutions contracted to make millions of doses of Johnson & Johnson and AstraZeneca’s respective vaccines from the plant. But an ingredient mix up reported in March rendered 15 million doses unusable, and Emergent has now halted…

Lonza’s alleged need for Nestlé staff highlights shortage in biopharma talent

by Dan Stanton

Neither company will confirm reports that Nestlé staff have been commandeered to help Lonza service its Moderna contract but the story highlights biomanufacturing staffing issues. A report by Reuters this week claims contract development and manufacturing organization (CDMO) Lonza is adding staff from fellow Swiss firm Nestlé in order to service a deal to produce drug substance for hundreds of millions of doses of Moderna’s COVID-19 vaccine. The “call for volunteers” following an intervention by the Swiss government aims at…

Moderna invests to increase global COVID-19 vaccine supply

by Millie Nelson

Moderna will make additional investments to increase global supply of its COVID-19 vaccine to potentially three billion doses in 2022. While no financial details of the investment have been divulged, the firm has confirmed it will provide additional funding to increase supply at its partnered and owned manufacturing sites this year with production expected to grow in late 2021 and early 2022. The increased investment will double drug substance manufacturing at CDMO Lonza’s plant in Visp, Switzerland. Lonza partnered with…